Chongqing introduced the second-class medical device registration fee standard, the first registration of 74,300 yuan
On December 20, Chongqing Municipal Food and Drug Administration issued the "Chongqing Food and Drug Administration's Announcement on Issuing the Registration Fees for Pharmaceuticals and Medical Device Products", in accordance with the statutory duties of the second category of medical devices (including in vitro diagnostics) Reagents) The first registration, change of registration, renewal of registration application for administrative acceptance, quality management system verification, technical review and other registration work, and the relevant fees are charged according to the standard. The standard will be implemented as of December 21, 2017. The fees associated with medical devices are as follows:
The second type of medical device product registration fee standard unit: yuan
The "Announcement" shows that the "Administrative Measures for the Registration of Medical Devices" and the "Administrative Measures for the Registration of In Vitro Diagnostic Reagents" are applications for the registration of changes in registration, and no application fee for change registration is charged. The first registration application for the second type of innovative medical device products proposed by small and micro enterprises is exempt from the initial registration fee. After the application for registration is accepted, if the applicant initiates the withdrawal of the application for registration, or the Chongqing Municipal Food and Drug Administration makes a decision not to grant permission, the registered registration fee will not be refunded. If the application for registration is filed again, the fee shall be repaid.
Up to now, a total of 20 provinces and municipalities have issued Class II medical device registration fees, as shown in the following figure.
(Source: Chongqing Food and Drug Administration)
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